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Pevion Biotech develops a state-of-the-art vaccine against recurrent vulvovaginal candidiasis (VVC) caused by the pathogenic form of Candida albicans especially in pre-menopausal women of childbearing age with a history of recurrent vulvovaginal candidiasis. This study is designed to evaluate the safety and tolerability of the vaccine, administered by two different routes (intramuscular and intravaginal) as primary endpoint. Immunogenicity will be evaluated as secondary endpoint.
Vaginal candidiasis is very common and may cause serious disorders and considerable costs. The current therapies, based on synthetic compounds, have suffered from the emergence of antifungal drug resistance. Clearly, new strategies to prevent Candida infections are needed.
To date, observations coming from studies in women with recurrent vulvovaginal candidiasis demonstrate that local immunity is more important for protection and clearance of infection than that provided by systemic host defense mechanisms. In mucosal immunity, humoral and cellular factors have been suggested to confer protection. Natural and monoclonal antibodies generated against Candida antigens have been proven to be protective against experimental Candida vaginitis in animal models when given prophylactically or therapeutically. After thorough preclinical testing for safety and efficacy, this is the first human clinical trial, evaluating a candidate Candida vaccine. The recombinantly produced Candida vaccine antigen is attached to influenza virosomes, a clinically validated carrier and adjuvant technology successfully employed for a variety of experimental and commercially available vaccines.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Recurrent Vulvovaginal Candidiasis
PEV7A1, PEV7A9, PEV7B2, PEV7B1
CHUV, Vaccine and Immunotherapy Center
Pevion Biotech Ltd
Published on BioPortfolio: 2014-08-27T03:15:56-0400
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A genus of yeast-like mitosporic Saccharomycetales fungi characterized by producing yeast cells, mycelia, pseudomycelia, and blastophores. It is commonly part of the normal flora of the skin, mouth, intestinal tract, and vagina, but can cause a variety of infections, including CANDIDIASIS; ONYCHOMYCOSIS; vulvovaginal candidiasis (CANDIDIASIS, VULVOVAGINAL), and thrush (see CANDIDIASIS, ORAL). (From Dorland, 28th ed)
Infection of the VULVA and VAGINA with a fungus of the genus CANDIDA.
An important nosocomial fungal infection with species of the genus CANDIDA, most frequently CANDIDA ALBICANS. Invasive candidiasis occurs when candidiasis goes beyond a superficial infection and manifests as CANDIDEMIA, deep tissue infection, or disseminated disease with deep organ involvement.
Candidiasis of the skin manifested as eczema-like lesions of the interdigital spaces, perleche, or chronic paronychia. (Dorland, 27th ed)
Autoimmune diseases affecting multiple endocrine organs. Type I is characterized by childhood onset and chronic mucocutaneous candidiasis (CANDIDIASIS, CHRONIC MUCOCUTANEOUS), while type II exhibits any combination of adrenal insufficiency (ADDISON'S DISEASE), lymphocytic thyroiditis (THYROIDITIS, AUTOIMMUNE;), HYPOPARATHYROIDISM; and gonadal failure. In both types organ-specific ANTIBODIES against a variety of ENDOCRINE GLANDS have been detected. The type II syndrome differs from type I in that it is associated with HLA-A1 and B8 haplotypes, onset is usually in adulthood, and candidiasis is not present.
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